Pronunciation: lok tor zee
Generic name: toripalimab-tpzi
Dosage form: injection single-dose vial (240 mg/6 mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
What is Loqtorzi?
Loqtorzi (toripalimab-tpzi) is an immunotherapy used to treat advanced nasopharyngeal carcinoma (NPC), a rare type of cancer of the nose or throat. Loqtorzi works by blocking the PD-1 receptor on tumor cells, which helps the immune system find and kill cancer cells. Loqtorzi is a monoclonal antibody that blocks PD-L1 and PD-L2, allowing the immune system to activate and kill the tumor. Loqtorzi is called a PD-1 inhibitor.
Loqtorzi is given as an intravenous infusion every two or three weeks, depending on your treatment regime.
Loqtorzi FDA approval was granted to Coherus BioSciences, Inc, on October 27, 2023, based on positive results from the Phase II clinical study POLARIS-02 and the Phase 3 clinical trial JUPITER-02 (NCT03581786).
Who can use Loqtorzi?
Loqtorzi FDA-approved indications are to treat adults as:
First-Line Treatment
- In combination with cisplatin and gemcitabine,
- When nasopharyngeal carcinoma cancer has spread to other parts of your body (metastatic) or,
- When cancer has returned (recurrent) in nearby tissues (locally advanced).
Subsequent Treatment:
- As a single agent ,
- You have received chemotherapy that contains platinum, and it did not work or is no longer working and,
- NPC has returned and cannot be removed with surgery or,
- Metastatic NPC that has progressed.
How well does Loqtorzi work?
In the JUPITER-02 Phase 3 clinical trial, Loqtorzi with gemcitabine/cisplatin was compared to placebo with gemcitabine/cisplatin treatment. It was a Phase 3, randomized, double-blind, placebo-controlled trial with 289 patients.
Key Findings:
Median Progression-Free Survival:
- 11.7 months in the Loqtorzi group
- 8.0 months in the placebo group
- 48% risk reduction for disease progression, hazard ratio (HR) for disease progression or death: 0.52 (95% CI, 0.36-0.74; P < .001)
Overall Survival (OS):
- 37% reduced the risk of death in the Loqtorzi +gemcitabine-cisplatin-treated groups compared to the placebo +gemcitabine-cisplatin-treated group in the 3-year survival follow-up of JUPITER-02
How does Loqtorzi work?
Usually, your immune system protects you by using T cells to detect and destroy germs and cells like cancer cells. Some cells including cancer cells can hide from the T cells, so they are not killed. These cells have proteins (PD-L1 and PD-L2) on the cell surface that bind to a protein (PD-1) on the T cells, which stops the T cells from killing it.
Loqtorzi works (mechanism of action) by binding to PD-1 on T cells which stops it from binding to PD-L1 and PD-L2 on the cancer cells, this leaves T cells and the immune system free to find and kill cancer cells.
Loqtorzi is a humanized IgG4 monoclonal antibody.
What is nasopharyngeal carcinoma?
Nasopharyngeal carcinoma (NPC) is an aggressive cancer that starts in the nasopharynx, which is the upper part of the throat behind the nose and near the base of the skull. Because of where the cancer is, surgery is rarely an option, so most patients whose cancer is localized are treated mainly with radiation and chemotherapy
Loqtorzi side effects
Common Loqtorzi side effects
The most common Loqtorzi side effects when Loqtorzi is used as a single therapy are tiredness, hypothyroidism, and musculoskeletal pain these side effects occur in 20% or more of patients.
The most common Loqtorzi side effects when used in combination with cisplatin and gemcitabine are nausea, vomiting, decreased appetite, constipation, low thyroid levels, rash, fever, diarrhea, peripheral neuropathy, cough, muscle and joint pain, upper respiratory infection, trouble sleeping, dizziness, and malaise, these side effects affected 20% or more of patients in the clinical trial JUPITER-02.
Serious Loqtorzi side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, skin sores, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Toripalimab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Loqtorzi may cause serious side effects. Call your doctor at once if you have:
- intestinal problems – severe stomach pain, diarrhea, bloody or tarry stools;
- liver problems – loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- immune system problems – confusion, problems with thinking or memory, balance problems, trouble breathing, weakness, muscle cramps, irregular heart rhythm or swelling of ankles;
- signs of organ transplant rejection – feeling sick or uneasy, with pain or swelling near your transplanted organ;
- signs of a hormonal disorder – unusual headaches, vision problems, feeling light-headed, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss;
- lung problems – cough, shortness of breath, chest pain;
- kidney problems – swelling, urinating less, feeling tired or short of breath; or
- low red blood cells (anemia) – pale skin, tiredness, feeling light-headed, cold hands and feet.
Your treatments may be delayed or permanently discontinued if you have certain side effects.
These are not all the possible side effects of Loqtorzi. Call your doctor for medical advice about side effects. You may report side effects to the FDA
Before taking this medicine
Tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have received radiation treatment to your chest area
- have had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.
Pregnancy
Loqtorzi can harm your unborn baby.
Tell you healhcare providers if you are pregnant or plan to become pregnant.
Females who are able to become pregnant should have a negative pregnancy test before you start treatment with Loqtorzi. You should use an effective method of birth control during your treatment and for 4 months after your last dose of this medicine. Talk to your healthcare provider about the best birth control methods that you can use during this time. Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Loqtorzi.
Breastfeeding
Do not breastfeed during treatment and for 4 months after the last dose of Loqtorzi.
Tell you healhcare providers if you are breastfeeding or plan to breastfeed. It is not known if Loqtorzi passes into your breast milk.
How will I receive Loqtorzi?
Loqtorzi is as a intravenous (IV) infusion into your vein through an intravenous (IV) line which takes 30 or 60 minutes. The IV infusion will be given to you by your healthcare provider.
Loqtorzi is usually given every two or three weeks.
Your healthcare provider will decide how many treatments you need.
You will need to have regular blood tests to check for certain side effects. If you miss any appointments, call your healthcare provider as soon as possible to reschedule.
Dosing information
Recommended adult Loqtorzi dose for First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine: 240 mg every three weeks.
Recommended adult Loqtorzi dose Previously Treated Unresectable or Metastatic NPC: 3 mg/kg every two weeks.
What happens if I miss a dose?
If you miss any appointments, call your healthcare provider as soon as possible to reschedule.
